(29 days)
The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. For breast biopsy this product is for diagnosis only - not for therapeutic use.
The SelectCore™ Variable Throw Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The device offers the user the choice of either single fire or fully automatic modes. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.
The provided text does NOT contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the SelectCore™ Variable Throw Biopsy Device, which focuses on establishing substantial equivalence to a predicate device.
Specifically, the "Performance Testing Summary" section (in {1}) states: "Performance testing confirms that the quality of samples obtained with the SelectCore™ Variable Throw Biopsy Device is equivalent to that of the predicate device." However, it does not provide details on:
- Specific acceptance criteria: There are no defined numerical or qualitative targets for device performance.
- The study design: No information is given about how the "quality of samples" was assessed, what metrics were used, or what kind of study was conducted.
- Any of the requested details about sample size, ground truth, expert involvement, or comparative effectiveness.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide the detailed study information. The provided text does not contain this level of detail.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.